Glucophage

"The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.

DRUG DESCRIPTION

GLUCOPHAGE® (metformin hydrochloride) Tablets and
GLUCOPHAGE® XR (metformin hydrochloride) Extended-Release Tablets are oral antihyperglycemic
drugs used in the management of type 2 diabetes. Metformin hydrochloride
(N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or
pharmacologically related to any other classes of oral antihyperglycemic
agents. The structural formula is as shown:

Metformin hydrochloride is a white to off-white crystalline
compound with a molecular formula of C4H11N5•
HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble
in water and is practically insoluble in acetone, ether, and chloroform. The
pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin
hydrochloride is 6.68.

GLUCOPHAGE tablets contain 500 mg, 850 mg, or 1000 mg of
metformin hydrochloride. Each tablet contains the inactive ingredients povidone
and magnesium stearate. In addition, the coating for the 500 mg and 850 mg
tablets contains hypromellose and the coating for the 1000 mg tablet contains
hypromellose and polyethylene glycol.

System Components and Performance

GLUCOPHAGE XR comprises a dual hydrophilic polymer matrix
system. Metformin hydrochloride is combined with a drug release controlling
polymer to form an “inner” phase, which is then incorporated as
discrete particles into an “external” phase of a second polymer.
After administration, fluid from the gastrointestinal (GI) tract enters the
tablet, causing the polymers to hydrate and swell. Drug is released slowly from
the dosage form by a process of diffusion through the gel matrix that is
essentially independent of pH. The hydrated polymer system is not rigid and is
expected to be broken up by normal peristalsis in the GI tract. The biologically
inert components of the tablet may occasionally remain intact during GI transit
and will be eliminated in the feces as a soft, hydrated mass.

What are the possible side effects of metformin (Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

What are the precautions when taking metformin hcl (Glucophage, Glucophage XR)?

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to metformin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before having surgery or any X-ray/scanning procedure using injectable iodinated contrast material, tell your doctor that you are taking this medication. You will need to temporarily stop this medication before...